Cycloset

"Nov. 15, 2012 -- The number of people diagnosed with diabetes in the U.S. jumped by 50% or more in 42 states and by more than 100% in 18 of those states in just under two decades, according to the latest snapshot from the CDC.

The recommended dose of Cycloset is 1.6 mg to 4.8 mg administered once daily within two hours after waking. Cycloset may interact with antidepressants, sedatives, narcotics, medicines to treat psychiatric disorders, antibiotics, antifungal medications, anti-malaria drugs, asthma or allergy medications, cancer medicines, medicines used to prevent organ transplant rejection, cholesterol-lowering drugs, oral diabetes medications, heart or blood pressure medications, heart rhythm medications, HIV/AIDS medications, seizure medications, erectile dysfunction medicines, or stomach acid reducers. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Cycloset is not expected to harm a fetus. However, a pituitary tumor in the mother can expand during pregnancy. High blood pressure can also occur during pregnancy and this drug could be dangerous if taken by a pregnant woman with high blood pressure. Consult your doctor. This drug lowers the hormone needed to produce breast milk. Do not breastfeed while taking Cycloset.

Our Cycloset (bromocriptine mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the
adverse reaction rates reported in one clinical trial may not be easily compared
to those rates reported in another clinical trial, and may not reflect the rates
actually observed in clinical practice.

The CYCLOSET (bromocriptine mesylate tablets) safety trial was a 52-week, placebo-controlled study that included
patients treated only with diet therapy or with other anti-diabetic medications.
A total of 3,070 patients were randomized to CYCLOSET (bromocriptine mesylate tablets) (titrated to 1.6 to 4.8
mg daily, as tolerated) or placebo. The study population had a mean baseline
age of 60 years (range 27-80) and 33% were 65 years of age or older. Approximately
43% of the patients were female, 68% were Caucasian, 17% were Black, 13% were
Hispanic, and 1% were Asian. The mean baseline body mass index was 32 kg/m².
The mean duration of diabetes at baseline was 8 years and the mean baseline
HbA1c was 7.0% with a mean baseline fasting plasma glucose of 142 mg/dL. At
baseline, 12% of patients were treated with diet only, 40% were treated with
one oral anti-diabetic agent, 33% were treated with two oral anti-diabetic agents,
and 16% were treated with insulin alone or insulin in combination with an oral
anti-diabetic agent. At baseline, 76% of patients reported a history of hypercholesterolemia,
75% reported a history of hypertension, 11% reported a history of revascularization
surgery, 10% reported a history of myocardial infarction, 10% reported a history
of angina, and 5% reported a history of stroke. Forty-seven percent of the CYCLOSET (bromocriptine mesylate tablets) -treated
patients and 32% of the placebo-treated patients prematurely discontinued treatment.
Adverse events leading to discontinuation of study drug occurred among 24% of
the CYCLOSET (bromocriptine mesylate tablets) -treated patients and 11% of the placebo-treated patients. This
between-group difference was driven mostly by gastrointestinal adverse events,
particularly nausea.

Table 1 summarizes the adverse events reported in ≥ 5% of patients treated
with CYCLOSET (bromocriptine mesylate tablets) in the phase 3 clinical trials regardless of investigator assessment
of causality. The most commonly reported adverse events (nausea, fatigue, vomiting,
headache, dizziness) lasted a median of 14 days and were more likely to occur
during the initial titration of CYCLOSET (bromocriptine mesylate tablets) . None of the reports of nausea or vomiting
were described as serious. There were no differences in the pattern of common
adverse events across race groups or age groups ( < 65 years old vs. > 65
years old). In the 52-week CYCLOSET (bromocriptine mesylate tablets) safety trial, 11.5% of CYCLOSET (bromocriptine mesylate tablets) -treated
women compared to 3.6% of placebo-treated women reported vomiting. In this same
trial, 5.4% of CYCLOSET (bromocriptine mesylate tablets) -treated men compared to 2.8% of placebo-treated men
reported vomiting.

†All randomized subjects receiving
at least one dose of study drug
‡ The Safety Trial enrolled patients treated with diet or no more
than 2 anti-diabetic medications (metformin, insulin secretagogues such
as a sulfonylurea, thiazolidinediones, alpha glucosidase inhibitors, and/or
Insulin)

Hypoglycemia

In the monotherapy trial, hypoglycemia was reported in 2 CYCLOSET (bromocriptine mesylate tablets) -treated patients
(3.7%) and 1 placebo-treated patient (1.3%). In the add-on to sulfonylurea trials,
the incidence of hypoglycemia was 8.6% among the CYCLOSET (bromocriptine mesylate tablets) -treated patients and
5.2% among the placebo-treated patients. In the CYCLOSET (bromocriptine mesylate tablets) safety trial, hypoglycemia
was defined as any of the following: 1) symptoms suggestive of hypoglycemia
that promptly resolved with appropriate intervention, 2) symptoms with a measured
glucose < 60 mg/dL or 3) measured glucose below 49 mg/dL regardless of symptoms.
In the 52-week safety trial, the incidence of hypoglycemia was 6.9% among the
CYCLOSET (bromocriptine mesylate tablets) -treated patients and 5.3% among the placebo-treated patients. In the
safety trial, severe hypoglycemia was defined as an inability to self-treat
neurological symptoms consistent with hypoglycemia that occurred in the setting
of a measured blood glucose < 50 mg/dl (or evidence of prompt resolution
of these symptoms with administration of oral carbohydrates, subcutaneous glucagon,
or intravenous glucose if blood glucose was not measured). In this trial, severe
hypoglycemia was reported among 0.5% of CYCLOSET (bromocriptine mesylate tablets) -treated patients and 1% of
placebo-treated patients.

Syncope

In combined phase 2 and 3 clinical trials, syncope was reported in 1.4% of
the 2,500 CYCLOSET (bromocriptine mesylate tablets) -treated patients and 0.6% of the 1,454 placebo-treated patients.
Among the 3,070 patients studied in the 52-week safety trial, 33 CYCLOSET (bromocriptine mesylate tablets) -treated
patients (1.6%) and 7 placebo-treated patients (0.7%) reported an adverse event
of syncope. The cause of syncope is not known in all cases [See WARNINGS
AND PRECAUTIONS]. In this trial, electrocardiograms were not available at
the time of these events, but an assessment of routine electrocardiograms obtained
during the course of the trial did not identify arrhythmias or QTc interval
prolongation among the CYCLOSET (bromocriptine mesylate tablets) -treated patients reporting syncope.

Central Nervous System

In the 52-week safety trial, somnolence and hypoesthesia were the only adverse
events within the nervous system organ class that were reported at a rate of
< 5% and ≥ 1% and that occurred at a numerically greater frequency among
CYCLOSET (bromocriptine mesylate tablets) -treated patients (CYCLOSET (bromocriptine mesylate tablets) 4.3% vs. Placebo 1.3% for somnolence; CYCLOSET (bromocriptine mesylate tablets)
1.4% vs. Placebo 1.1% for hypoesthesia).

Serious Adverse Events and Cardiovascular Safety

The primary endpoint of the 52-week safety trial was the occurrence of all
serious adverse events. A secondary endpoint was the occurrence of the composite
of myocardial infarction, stroke, coronary revascularization, hospitalization
for angina, and hospitalization for congestive heart failure.

Postmarketing Experience

The active agent in CYCLOSET (bromocriptine mesylate) has been used in other
formulations and often multiple times per day to treat hyperprolactinemia, acromegaly,
and Parkinson's disease. The following adverse reactions have been identified
during postapproval use of bromocriptine mesylate for these indications, generally
at doses higher than those approved for the treatment of type 2 diabetes. Because
these reactions are reported voluntarily from a population of uncertain size,
it is generally not possible to reliably estimate their frequency or establish
a causal relationship to drug exposure.

Hallucinations

Hallucinations and mental confusion including delusions have been reported
with bromocriptine. To date, there have been no reported cases of hallucinations
or delusions among CYCLOSET (bromocriptine mesylate tablets) -treated patients (n= 2500) in combined Phase 2 and
3 clinical trials of CYCLOSET (bromocriptine mesylate tablets) .

Fibrotic - Related Complications

Fibrotic complications, including cases of retroperitoneal fibrosis, pulmonary
fibrosis, pleural effusion, pleural thickening, pericarditis and pericardial
effusions have been reported. These complications do not always resolve when
bromocriptine is discontinued. Among several studies investigating a possible
relation between bromocriptine exposure and cardiac valvulopathy, some events
of cardiac valvulopathy have been reported, but no definitive association between
bromocriptine mesylate use and clinically significant (moderate to severe) cardiac
valvulopathy could be concluded.

No cases of cardiac valvulopathy have been reported in any of the clinical
studies to date with CYCLOSET (bromocriptine mesylate tablets) .

Psychotic and Psychiatric Disorders

Psychotic disorders have been reported with bromocriptine. Additionally, pathological
gambling has been reported with bromocriptine used to treat patients with Parkinson's
disease. To date, there have been no reported cases of psychoses or pathological
gambling among the CYCLOSET (bromocriptine mesylate tablets) -treated patients (N=2500) in combined Phase 2 and
3 controlled clinical trials of CYCLOSET (bromocriptine mesylate tablets) .

Stroke

The indication for use of bromocriptine for inhibition of postpartum lactation
was withdrawn based on postmarketing reports of stroke. Causality of bromocriptine
use and the occurrence of stroke in this patient population has not been proven.
Based on the CYCLOSET (bromocriptine mesylate tablets) clinical trials, there is no evidence of increased risk
for stroke when CYCLOSET (bromocriptine mesylate tablets) is used to treat type 2 diabetes.

Neuroleptic - like malignant syndrome

A neuroleptic-like malignant syndrome (manifested by high fever and increase
in creatinine phosphokinase) has been reported upon cessation of bromocriptine
treatment in patients with advanced Parkinson's disease or patients with secondary
Parkinsonism. To date, there have been no reported cases of neuroleptic-like
malignant syndrome in combined Phase 2 and 3 controlled clinical trials of CYCLOSET (bromocriptine mesylate tablets) ,
including the Safety Trial (N=2500). In the CYCLOSET (bromocriptine mesylate tablets) Safety Trial, there were
no reports of neuroleptic-like malignant syndrome during the 30 days of follow-up
after cessation of CYCLOSET (bromocriptine mesylate tablets) (N = 2054).